Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15429

Study information

Scientific title

IciCLLe: Assessment of the Mechanism of Action of Ibrutinib (PCI-32765) in B-cell Receptor Pathway Inhibition in CLL

Acronym

IciCLLe

Study hypothesis

The aim of this feasibility study is to confirm the mechanism of action of Ibrutinib. Results will then inform the design of a randomized phase II/III trial using response as the primary outcome measure to determine whether Ibrutinib shows sufficient evidence of activity in these cohorts of patients.

Cohort B (Relapsed/Refractory)1. CLL requiring therapy2. Refractory CLL defined as any of the following:3. Failure to achieve a response (CR or PR by IWCLL Criteria) to a purine analogue alone or in combination with chemotherapy, or:4. Relapse within 6 months of responding to a purine analogue alone or in combination with chemotherapy, or:5. Relapse within 24 months of responding to a fludarabine, cyclophosphamide and rituximab (FCR), or:6. Patients with CLL with deletion of chromosome 17p who have failed at least one previous therapy.7. ECOG performance status (PS) of 0, 1, or 2 (see appendix 6)8. Life expectancy of at least 6 months9. Prepared to undergo the stipulated investigations within the trial (including bone marrow examinations)10. Age = 1811. Able to give informed consentTarget Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Participant exclusion criteria

Both cohorts A and B1. Unwilling to undergo the protocol assessments including the bone marrow assessments2. Active infection3. Other severe, concurrent (particularly cardiac or pulmonary) diseases or mental disorders that could interfere with their ability to participate in the study4. Use of prior investigational agents within 6 weeks5. Pregnancy or lactation6. Unwilling to use appropriate contraception during and for 12 months following treatment7. CNS involvement with CLL8. Mantle cell lymphoma9. Known HIV positive10. Active or prior Hepatitis B or C11. Active secondary malignancy excluding basal cell carcinoma12. Persisting severe panocytopenia (nNeutrophils <0.5 x109/L) or transfusion dependent anaemia unless due to direct marrow infiltration by CLL (to be confirmed via bone marrow biopsy)13. Active haemolysis (not controlled with Prednisolone at 10 mg or less)14. Patients requiring or who have received anticoagulation treatment with warfarin or vitamin K antagonists within 1 week of the first dose of ibrutinib15. Patients requiring concomitant use of strong CYP3A4/5 inhibitors16. Patients with evidence or history of transformation and/or PLL

Cohort A (Treatment naive)1. Previous treatment for CLL. This does not include steroids.